Gilotrif Side Effects

Generic Name: afatinib

Note: This page contains information about the side effects of afatinib. Some of the dosage forms included on this document may not apply to the brand name Gilotrif.

Not all side effects for Gilotrif may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to afatinib: oral tablet

Along with its needed effects, afatinib (the active ingredient contained in Gilotrif) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking afatinib:

More common
  • Bloody or cloudy urine
  • burning, dry, or itching eyes
  • diarrhea
  • difficult, burning, or painful urination
  • discharge or excessive tearing
  • fever
  • frequent urge to urinate
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • tingling of the hands and feet
  • ulceration of the skin
Less common
  • Cough
  • difficult breathing
  • shortness of breath

Get emergency help immediately if any of the following symptoms of overdose occur while taking afatinib:

Symptoms of overdose
  • Abdominal or stomach pain
  • dizziness
  • headache
  • lack or loss of strength
  • nausea
  • vomiting

Some side effects of afatinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Blemishes on the skin
  • canker sores
  • chapped, red, or swollen lips
  • decreased appetite
  • decreased weight
  • dry skin
  • itching skin
  • loosening of the fingernails
  • nosebleeds
  • pimples
  • rash
  • redness or soreness around the fingernails
  • runny nose
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

For Healthcare Professionals

Applies to afatinib: oral tablet

General

The most frequent serious adverse reactions reported were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).

Dose reductions due to adverse reactions were required in 57% of patients. The most frequent adverse reactions that led to dose reduction were diarrhea (20%), rash/acne (19%), paronychia (14%), and stomatitis (10%).

Discontinuation of therapy for adverse reactions was 14.0%. The most frequent adverse reactions that led to discontinuation were diarrhea (1.3%), ILD (0.9%), and paronychia (0.9%).

Gastrointestinal

Very common (10% or more): Diarrhea (96%), stomatitis (71%), cheilitis (12%)

Dermatologic

Very common (10% or more): Acneiform rash/dermatitis (90%), paronychia (58%), dry skin (31%), pruritus (21%)

Genitourinary

Very common (10% or more): Cystitis (13%)

Hepatic

Very common (10% or more): Alanine aminotransferase increased (11%)
Common (1% to 10%): Aspartate aminotransferase increased (8%)

Metabolic

Very common (10% or more): Decreased appetite (29%), weight decreased (17%)

Ocular

Very common (10% or more): Conjunctivitis (11%)

Other

Very common (10% or more): Pyrexia (12%)

Respiratory

Very common (10% or more): Epistaxis (17%), rhinorrhea (11%)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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